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The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers.
The main objective of this study is to evaluate the bioequivalency of two preparations of ensartinib capsules in Chinese healthy volunteers under fasted state or after meal. In addition, the safety of single dose administration of ensartinib capsules in Chinese healthy volunteers will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T-R cohort under fasted state | Experimental | Subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state. |
|
| R-T cohort under fasted state | Experimental | Subjects will be administered with one single dose of ensartinib capsules (reference product) under fasted state, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) under fasted state. |
|
| T-R cohort after meal | Experimental | Subjects will be administered with one single dose of ensartinib capsules (test product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (reference product) after meal. |
|
| R-T cohort after meal | Experimental | Subjects will be administered with one single dose of ensartinib capsules (reference product) after meal, after a wash period of 14 days,the subjects will be administered with one single dose of ensartinib capsules (test product) after meal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ensartinib capsules (test product) | Drug | Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration(Cmax) of ensartinib(test product) after meal | The Cmax of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Peak plasma concentration(Cmax) of ensartinib(test product) under fasted sate | The Cmax of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Peak plasma concentration(Cmax) of ensartinib(reference product) after meal | The Cmax of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Peak plasma concentration(Cmax) of ensartinib(reference product) under fasted sate | The Cmax of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) after meal | The AUC of ensartinib(test product) in after meal blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Area under the plasma concentration versus time curve(AUC) of ensartinib(test product) under fasted sate |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with adverse events as assessed by CTCAE v4.03 | from screening to post-study visit, assessed up to 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tongyu Zhu | Shanghai Public Health Clinical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 201508 | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000629294 | ensartinib |
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|
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| ensartinib capsules (reference product) | Drug | Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions |
|
|
The AUC of ensartinib(test product) in fasting blood samples of each subject over a 120 hour period post dose
| pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) after meal | The AUC of ensartinib(reference product) in after meal blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| Area under the plasma concentration versus time curve(AUC) of ensartinib(reference product) under fasted sate | The AUC of ensartinib(reference product) in fasting blood samples of each subject over a 120 hour period post dose | pre-dose(60minute),30min,1,1.5,2,2.5,3,3.5,4,4.5,5,6,8,12,24,36,48,72,96,120hour |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |